From cadavers to implants: silicon tissue assays of medical devices.

Abstract

A plethora of data has been used to condemn and defend the role of silicone and its association with "adjuvant disease." In the ongoing attempt to enhance our knowledge, we have chosen to identify tissue silicon levels in patients with saline implants or tissue expanders. We have compared these levels with tissue samples from a variety of patients with and without medicinal silicone devices from both the northeast and southwest United States over a 4-year period. All specimens were harvested by a "no touch" technique, non-formalin fixed, frozen, and shipped to an independent toxicology laboratory for analysis. Inductively coupled plasma atomic emission spectroscopy was used to obtain the tissue silicon measurements. Silicon tissue values in cadaveric tissue (n = 20 cadavers; n = 120 specimens) averaged 2.2 mcg/gm of tissue with undetectable silicon levels in over 50 percent of the specimens (range 0 to 45 mcg/gm; median = 0). Silicon levels surrounding port-a-catheter devices (n = 15 patients; n = 15 specimens) averaged 8.04 mcg/gm of tissue (range 0 to 41 mcg/gm; median = 0). Tissue levels in the capsules surrounding saline (n = 10 patients; n = 22 specimens) and silicone implants (n = 31 patients; n = 58 specimens) averaged 292 mcg/gm (range 0 to 1380 mcg/gm; median = 110) and 1439 mcg/gm (range 0 to 9800 mcg/gm, median = 490), respectively. Tissue levels, however, from distant sites (n = 22 specimens) in these same patients were equivalent to the cadaveric nonaugmented values (average = 3.2 mcg/gm; range 0 to 5.8 mcg/gm; median = 2.7). The results imply that there is a continuum of exposure to silicone medical devices based on the mechanical properties of silicone. The data seem to suggest that there may be a progression of measurable tissue silicon levels based on the amount of environmental or device-related silicone exposure a person has over his or her lifetime. It is our hope that these levels will serve as a baseline for our continuing knowledge of implantable medical devices.